RESOLUTION - RDC NO. 579 OF NOVEMBER 25th 2021
Provides for the import, marketing, and donation of used and refurbished medical devices.
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Provides for the import, marketing, and donation of used and refurbished medical devices.
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Establishes mandatory execution and notification of field actions by medical device registration holders in Brazil.
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It provides the essential safety and efficacy requirements for health products.
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Provisions regarding post-market surveillance applicable to registration holders of health product in Brazil.
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Describes the classification of risks, notification and registration control systems, and labeling and instructions for use requirements, for in vitro diagnostic products, including their instruments, and gives other provisions.
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